Diarrhea and inflammatory gut disorders are a major and increasing health cost in the US and other countries. Inflammatory bowel disease (IBD) affects an estimated 600,000 Americans a year. IBD commonly refers to ulcerative colitis (UC) and Crohn's disease (CD), which are chronic inflammatory diseases of the gastrointestinal tract of unknown etiology. Crohn's disease is also referred to as regional enteritis, terminal ileitis, or granulomatous ileocolitis. Increasing evidence suggests that, at least in CD, there is a defect in the function of the intestinal immune system. As a consequence, there is a breakdown of the defense barrier of the gut, which, in turn, results in exposure of the mucosa to microorganisms or their products. The result is a chronic inflammatory process mediated by T cells.
Inflammation normally is a localized, protective response to trauma or microbial invasion that destroys, dilutes, or walls-off the injurious agent and the injured tissue. It is characterized in the acute form by the classic signs of pain, heat, redness, swelling, and loss of function. Microscopically, it involves a complex series of events, including dilation of arterioles, capillaries, and venules, with increased permeability and blood flow, exudation of fluids, including plasma proteins, and leukocyte migration into the area of inflammation.
Other diseases of the gastrointestinal tract also have an enormous impact on health. According to the American Cancer Society 154,000 new cases of colorectal cancer will be diagnosed in the U.S. in 2007. With an average cost of between $35,000 and $80,000 for direct medical care for each cancer episode, total cost for treatment of anticipated new cases in 2007 is estimated at $8.3 billion. Thus, there is a need for new and effective treatments for gastrointestinal disorders.
It is an object of the invention to provide compositions and methods for the treatment of one or more symptoms of a disorder of the gastrointestinal tract.
It is another object of the invention to provide compositions and methods for the treatment of cancer.
It is still another object of the invention to provide compositions and methods for inflammatory disorders.
It is yet another object of the invention to provide compositions and methods for treating diarrhea.